Cinryze regulatory update

ViroPharma disclosed in its 4Q11 earnings call that in early April it will submit a response to FDA's complete response letter regarding industrial scale manufacturing expansion activities for hereditary angioedema (HAE) drug Cinryze. The company anticipates a 4-month review, with a decision expected in early August. Last month, ViroPharma received the letter in which FDA made 3 comments related to a portion of the cleaning validation for industrial scale manufacturing (see BioCentury, Feb. 13). The company markets the IV complement 1 (C1) esterase inhibitor in the EU for the treatment and pre-procedure and routine prevention of angioedema attacks in HAE patients ages 6 years and older, and in the U.S. for routine prophylaxis of acute attacks of HAE. ...